- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02808208
Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
April 5, 2024 updated by: Sanjay Misra, M.D., Mayo Clinic
A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.
Study Overview
Status
Active, not recruiting
Study Type
Interventional
Enrollment (Estimated)
74
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- Patient between 18 and 85 years old
- Patient currently on hemodialysis or pre-dialysis and planned creation of an upper extremity AV fistula with suitable anatomy
- Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
- Life expectancy of at least 24 months
Exclusion Criteria
- Malignancy or treatment for malignancy within the previous 6 months
- Immunodeficiency including AIDS / HIV or Active autoimmune disease
- Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
- Pregnancy or breast feeding
- Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF
- Employees of the sponsor or patients who are employees or relatives of the investigator
- History of failed organ transplant on immunosuppression
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)
|
A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.
|
No Intervention: No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Patients receive standard of care.
|
|
Experimental: Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula
Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF
|
A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.
|
Experimental: AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula
Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF
|
Two topical applications of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period at stage one and two of fistula surgery
|
Placebo Comparator: Placebo treatment in brachiobasilic arteriovenous fistula
Subjects will receive placebo at first and second stage of BBF
|
5-mL of Lactated Ringers solution topical application to the surface of the outflow vein (right next to the fistula) over a five-minute period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemodialysis outflow vein diameter
Time Frame: Baseline to 12 months after AVF creation
|
Diameter of outflow vein by ultrasound
|
Baseline to 12 months after AVF creation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemodialysis AVF Blood flow
Time Frame: Baseline to 12 months after AVF creation
|
blood flow by ultrasound or dialysis
|
Baseline to 12 months after AVF creation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjay Misra, M.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2017
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
June 2, 2016
First Submitted That Met QC Criteria
June 16, 2016
First Posted (Estimated)
June 21, 2016
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Congenital Abnormalities
- Renal Insufficiency
- Pathological Conditions, Anatomical
- Renal Insufficiency, Chronic
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Failure, Chronic
- Fistula
- Arteriovenous Fistula
Other Study ID Numbers
- 15-009053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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